| January 23, 2008 |
| October 9, 2009 |
| October 2006 |
| October 2009 (final data collection date for primary outcome measure) |
| The specific aim of this study is to assess the efficacy, tolerability, and safety of duloxetine compared with placebo in outpatients with binge eating disorder and a comorbid depressive disorder. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ] |
| Same as current |
| Complete list of historical versions of study NCT00607789 on ClinicalTrials.gov Archive Site |
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| A 12-Week, Double-Blind, Placebo-Controlled, Trial of Duloxetine Versus Placebo in the Treatment of Binge Eating Disorder and Comorbid Depressive Disorder |
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The purpose of this research study is to test the safety of duloxetine and see what effects (good and bad) it has on you and your binge eating disorder and comorbid depressive disorder (depression occurring with binge eating disorder) compared to placebo (inactive pill). |
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| Phase IV |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
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- Drug: duloxetine
- Drug: placebo
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| Completed |
| 40 |
| October 2009 |
| October 2009 (final data collection date for primary outcome measure) |
Inclusion criteria:
Exclusion Criteria:
- Women who are pregnant, breastfeeding, or of childbearing potential who are not using a medically acceptable, effective method of birth control. Women of childbearing potential include all pre-menopausal women biologically capable of becoming pregnant or contributing a fertilizable ovum. Medically acceptable methods of birth control include oral contraceptives, an intrauterine device, use of two combined barrier methods, or surgical sterilization.
- Patients who display significant risk for suicide.
- Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for MDD or obesity for at least 3 months prior to randomization.
- A DSM-IV diagnosis of alcohol or substance abuse or dependence, bulimia nervosa, or anorexia nervosa within the 6 months prior to randomization.
- Patients with a lifetime DSM-IV history of a psychotic disorder, a bipolar disorder, or dementia.
- Patients with a history of psychosurgery
- Patients with an Axis II disorder (personality disorders such as schizotypal, borderline, or antisocial), which might interfere with a diagnostic assessment, treatment, or compliance.
- Patients with clinically unstable medical disease, including cardiovascular, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, treatment, or assessment of MDD or obesity. Patients should be euthyroid to enter the study.
- Patients with hepatic insufficiency
- Patients with end-stage renal disease or severe renal impairment
- Patients with a history of seizures, including febrile seizures in childhood.
- Patients requiring treatment with any drug which might interact adversely with or obscure the action of the study medication.
- Patients with a known hypersensitivity to duloxetine or any of the inactive ingredients of duloxetine (Cymbalta).
- Patients with uncontrolled narrow-angle glaucoma.
- Patients with clinically relevant abnormal laboratory results, specifically including hypokalemia.
- Patients who have received monoamine oxidase inhibitors, tricyclics, antipsychotics, lithium, or fluoxetine within four weeks prior to randomization.
- Patients who have received other psychoactive medications (including appetite suppressants) or any anti-obesity medications within one week prior to randomization.
- Patients who have received investigational medications or depot neuroleptics within three months prior to randomization.
- Patients previously enrolled in this study or who have previously been treated with duloxetine.
- Subject considered by the investigator as unable to be followed up throughout the entire duration of the study.
- Patients taking medications that inhibit the P450-2D6 hepatic isoenzyme
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00607789 |
| Erik B. Nelson, MD & Susan McElroy, University of Cincinnati & Lindner Center of HOPE |
| Nelson #2 |
| University of Cincinnati |
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| Principal Investigator: |
Erik B Nelson, MD |
University of Cincinnati |
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| University of Cincinnati |
| October 2009 |